547903
AFAM Concept, Inc. — FEI 3003818194
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 11, 2008
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 1637 | 21 CFR 211.130(e) | Packaging line inspection after use |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4327 | 21 CFR 211.122(c) | Records fail to include |
| 4576 | 21 CFR 211.192 | No written record of investigation |